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U.S. FDA Medical Device Gastro-Urology Trocar Requirements

FDA Medical Device Definition: A suprapubic urological catheter and accessories is a flexible tubular device that is inserted through the abdominal wall into the urinary bladder with the aid of a trocar and cannula. The device is used to pass fluids to and from the urinary tract. This generic type of device includes the suprapubic catheter and tube, Malecot catheter, catheter punch instrument, suprapubic drainage tube, and the suprapubic cannula and trocar.

Registrar Corp assists Gastro-Urology Trocar companies with:

  • FDA Gastro-Urology Trocar Establishment Registration
  • FDA Gastro-Urology Trocar Listing
  • FDA Gastro-Urology Trocar Label Requirements and Exceptions
  • FDA Gastro-Urology Trocar Import Information
  • FDA Gastro-Urology Trocar Detentions (Gastro-Urology Trocar Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Gastro-Urology Trocar Manufacturers (Gastro-Urology Trocar Suppliers)
       - Gastro-Urology Trocar Distributors
       - Gastro-Urology Trocar Processors
       - Gastro-Urology Trocar Repackers
       - Gastro-Urology Trocar Relabelers
       - Gastro-Urology Trocar Exporters
       - Gastro-Urology Trocar Importers
For more information about Gastro-Urology Trocar Medical Devices, simply click below:

U.S. FDA Regulations:

U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.

Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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